Clinical trial · Interventional
Early Endoscopic Ultrasound - Based Sphincterotomy or Conservative Treatment in Severe Biliary Pancreatitis
Randomised Multicenter Trial of Early EUS Followed by Endoscopic Sphincterotomy in Case of Bile Duct Stone vs Conservative Treatment in Severe Biliary Pancreatitis
NCT00987428CI-TRIAL-00097640EEPAB2terminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Insufficient number of participants
Summary
Brief summary (as posted)
The primary purpose of this trial is to determine whether an early Early Endoscopic Ultrasound (EUS) immediately followed by an endoscopic sphincterotomy (ES) in case of bile duct stones may improve outcomes in patients with predicted severe acute biliary pancreatitis (ABP).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatitis Acute Biliary | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ultrasonography with or not sphincterotomy | Procedure | — | UNRESOLVED |
| Usual procedure | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- groupe 1
- description
- Early endoscopic ultrasonography and endoscopic sphincterotomy in case of common bile duct stone
- interventionNames
- Procedure: ultrasonography with or not sphincterotomy
- type
- ACTIVE_COMPARATOR
- label
- Groupe 2
- description
- usual procedure
- interventionNames
- Procedure: Usual procedure
Primary outcomes (1)
- measure
- The difference between the SOFA score measured at entry in the study (day 0) and at day 8
- timeFrame
- Day 8
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion criteria : * age \> 18 * predicted severe acute biliary pancreatitis (including age \> 80, BMI \>30, pre-existing organ failure, Modified Glasgow score \> 3) * timespan between onset and randomization \< 48 hrs * informed consent signed by patient or liable person in case of emergency Exclusion criteria : * non biliary pancreatitis * non severe pancreatitis * age \< 18 * timespan between onset and randomization \> 48 hrs * absence of consent * ongoing pregnancy * no social security insurance
References
Publications (0)
Data not yet available
No reference posted for this study.